Kornimate/medical-research-clean huggingface dataset:
erlotinib in treating patients with recurrent or progressive glioblastoma multiforme

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: erlotinib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. purpose: phase ii trial to study the effectiveness of erlotinib in treating patients who have recurrent or progressive glioblastoma multiforme.

objectives: * determine the response rate of patients with recurrent or progressive glioblastoma multiforme treated with erlotinib. * determine the progression-free and overall survival of patients treated with this drug. outline: patients receive oral erlotinib daily. treatment continues in the absence of disease progression or unacceptable toxicity. patients are followed for survival. projected accrual: a total of 73 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed glioblastoma multiforme * radiographic evidence of recurrence or progression * biopsies to confirm tumor recurrence allowed if a sufficent percentage of cases are confirmed to be recurrent tumor * previously treated with optimal radiotherapy and at least 1 cytotoxic chemotherapy regimen patient characteristics: age * 18 and over performance status * not specified life expectancy * not specified hematopoietic * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic * bilirubin no greater than 2 times normal * alkaline phosphatase no greater than 2 times normal * alt no greater than 3 times normal renal * bun no greater than 1.5 times normal or * creatinine no greater than 1.5 times normal other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no medical condition that would interfere with oral administration of erlotinib * no other medical or psychiatric illness that would preclude study therapy * no active infection * no other malignancy within the past 3 years except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer prior concurrent therapy: biologic therapy * no concurrent immunotherapy for brain cancer * no concurrent biologic therapy for brain cancer chemotherapy * see disease characteristics * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * no concurrent chemotherapy for brain cancer endocrine therapy * concurrent glucocorticosteroids allowed * no concurrent hormonal therapy for brain cancer radiotherapy * see disease characteristics surgery * not specified other * no prior epidermal growth factor receptor (egfr) inhibitor * no concurrent egfr inhibitor * no other concurrent antineoplastic therapy * no concurrent anti-epileptic agents other than modest- or non-enzyme-inducing drugs such as the following: * gabapentin * lamotrigine * divalproex * felbamate * levetiracetam * tiagabine * topiramate * zonisamide

Keywords: adult glioblastoma recurrent adult brain tumor adult giant cell glioblastoma adult gliosarcoma
real time evaluation of dynamic changes of the lungs during respiratory support of vlbw neonates using eit

Conditions: RDS - Infants; RDS of Prematurity; Respiratory Failure; Prematurity; Very Low Birth Weight Infant

Summary: electric impedance tomography (eit) is a lung monitoring technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax. it is a real time, radiation free, non-invasive and portable. neonatal respiratory distress syndrome (rds) is a respiratory disorder resulting from immaturity of the lung structure and lack of surfactant. it is one the most common conditions in premature infants. many of these infants require either invasive or non-invasive respiratory support. the goal of the study is to investigate the dynamic changes in pulmonary aeration during assisted breathing in very low birthweight preterm infants using pulmonary electrical impedance tomography. currently most widely used methods to assess respiratory lung function are either invasive and/or indirect (abg, pulse oximetry, transcutaneous pco2 measurement), lacks temporal resolution (lung ultrasound) or emit ionizing radiation (ct). eit provides information on regional lung aeration without the aforementioned shortcomings.


Eligibility criteria:
inclusion criteria: * gestational age \<32 weeks or birthweight \<1500 g. * need of respiratory therapy (invasive or non-invasive) * parental consent. exclusion criteria: * patient does not meet all of the above listed inclusion criteria * patients with a pacemaker * patients with skin damage/abrasions at the eit device belt area * newborns with significant thoracic deformity

Keywords: electrical impedance tomography
comparison of bolus dosing of methohexital and propofol in elective direct current cardioversion

Conditions: Atrial Fibrillation; Atrial Flutter

Summary: a randomized, open-blinded, prospective study to evaluate the timeliness and safety of direct current cardioversion (dccv) when using methohexital when compared to the more often used propofol.

the investigators theorize that the use of methohexital during cardioversion will result in a shorter time to effective sedation and time to full recovery when compared to the use of propofol. this will change how sedation is approached for elective cardioversions. primary hypothesis: 1. the mean time to recovery from sedation during a cardioversion using methohexital for sedation will be significantly shorter than the recovery time using propofol for sedation, as evidenced by a short time from initiation of induction to a score of 2 on the ramsay sedation scale. 2. the mean time to a ramsay score of 5-6 will be significantly shorter using methohexital than the time to the same sedation level using propofol secondary hypothesis: 1. there will be no significant increase in adverse events associated with the use of methohexital when compared with propofol.

Eligibility criteria:
inclusion criteria: * patients who present to wake forest baptist medical center for a direct current cardioversion for treatment of paroxysmal or persistent atrial fibrillation as well as atrial flutter. exclusion criteria: * patients with sedation for transesophageal echocardiogram within 30 minutes of dccv * hemodynamically compromised patients (as defined by hypotension \<90/50 mmhg, altered mental status, shock, ischemic chest discomfort, or heart failure)

Keywords: cardioversion propofol deep sedation intravenous anesthetics
the effect of inspiratory muscle training on breast cancer patients undergoing surgery

Conditions: Post-operative Breast Cancer

Summary: this study will address the female patients who are exposed to surgery after breast cancer. strength training for the inspiratory muscles will be applied in addition to the traditional care including physical therapy that will be compared to the effect of the traditional care alone on multiple outcome measures such as muscle strength, function, fatigue, and stress.

saudi arabia reported 24,485 new cases of cancer in 2018 with 10518 cancer deaths. there were genetic, hormonal, lifestyle, obesity, and environmental risk factors associated with different cancer types. many of the side effects of cancer and its treatments are burdensome and significantly impact the quality-of-life quality. exercise before, during, and after cancer treatment provides numerous beneficial outcomes such as improving physical capacity, muscle power, and psychological status. exercise is a valuable therapeutic tool for lowering acute, long-term, and late adverse effects of cancer. for breast cancer patients, physiotherapy is a crucial component of treatment. the physical therapy exercise program helps patients regain fitness, reduce pain, and reduce side effects caused by different cancer treatment methods. respiratory physiotherapy is a useful procedure for maintaining and improving functional capacity, quality of life, and post-treatment sequelae after breast cancer management, which is a combination of strategies aimed at preventing, treating, and stabilizing cardiorespiratory disorders in adults. this study aimed to evaluate the effectiveness of inspiratory muscle training in post-surgical breast cancer survivors.

Eligibility criteria:
inclusion criteria: * post-operative breast cancer female patients * age ≥40 years * all patients with eastern cooperative oncology group performance status score ≤ 2 * having to undergo primary treatment with surgery exclusion criteria: * severe anemia (hb ≤ 8 g/dl) * presence of underlying chronic cardiac or respiratory disease * severe infection, neurologic or muscular diseases prohibiting physical activity * uncontrolled and/or extensive brain metastases, or bone metastases that were assessed to pose a risk of pathological fractures from exercising * contraindications descriped by the physician
18f-her2 pet in evaluating the efficacy of anti-her2 therapy for urothelial carcinoma.

Conditions: 18F-HER2 PET

Summary: this is a open-label, one-arm, multicenter study aimed to explore the efficacy and safety of 18f-her2 pet in evaluating the efficacy of anti-her2 therapy for urothelial carcinoma.


Eligibility criteria:
inclusion criteria: 1. informed consent document must be signed. 2. aged 30-80 years old, both genders. 3. patients with locally advanced or advanced urothelial carcinoma 4. patients plan to undergo anti her2 treatment. exclusion criteria: 1. subjects with active malignancies other than urothelial carcinoma within 5 years should be excluded. 2. patients with severe liver, kidney, and hematopoietic diseases 3. patients with other mental disorders or primary emotional disorders 4. those who are unable to understand, comply with the research protocol, or sign an informed consent form 5. pet imaging contraindication (including pregnant women, lactating women, women of childbearing age who have a recent fertility plan, etc.) 6. individuals who are allergic to imaging agents 7. hypoglycemic reactions, severe pain, etc. cannot be accompanied by pet scans
dbt skills expanded with contextual intervention for long lasting symptoms in borderline personality disorder

Conditions: Borderline Personality Disorders; BPD

Summary: although borderline personality disorder (bpd) tend to the clinical remission in long-term follow-up studies, a significant subgroup of patients continues to present long lasting symptoms such as low mood, emptiness and persistent impairment in psychosocial adjustment. the prevalence of this subsample of individuals is considerably increasing last years. new interventions addressed to these individuals are need, the aim of this study is to evaluate the efficacy of a novel intervention combining dialectical behavioral therapy skills training with self-compassion and contextual-based skills for patients with long-lasting bpd.

sixty individuals with bpd and long lasting symptoms that have been received previously dialectical-behavioral therapy skills training (dbt-st) will be included in a randomized clinical trial. they will be randomly assigned to receive an add-on skills training intervention involving the combination of dbt-st, self-compassion, and contextual-based skills for long lasting symptoms versus treatment as usual during 12-weeks. patients will be evaluated pre and post intervention and 3-month follow-up. the outcome measures are well-being indicators and clinical variables.

Eligibility criteria:
inclusion criteria: * adults between 18 and 65 years of age * primary diagnosis of bpd according to diagnostic statistical manual iv criteria and by the structured interviews: diagnosis structured clinical interview for axis ii personality disorders (scid ii; first et al. 1997) and diagnostic interview for borderlines revised (dib-r) * previous participation in dbt-st intervention * signed informed consent. exclusion criteria: * presence of life-threatening behaviors in the last 12 months * ptsd or related symptoms * diagnosis of drug-induced psychosis, organic brain syndrome, bipolar or psychotic disorder * intellectual disability * participation in any other psychotherapy treatment during the study.

Keywords: borderline personality disorder long-lasting symptoms dialectical behavior therapy skills contextual approach.
high risk factor, clinical feature, and follow up of neonatal arrhythmia

Conditions: Neonatal Arrhythmia

Summary: this study included 189 newborns (77 male,112 female) diagnosed with arrhythmia in the nicu of children's hospital of chongqing medical university, china, from january 2015 through december 2019. to investigate the high-risk factors, clinical manifestations, and clinical outcomes of neonatal arrhythmia.

the incidence of neonatal arrhythmia is 3.94‰(189/47911), and the mortality of neonatal arrhythmia is 0.21‰(10/47911) within 1 year after birth.

Eligibility criteria:
inclusion criteria:①newborns admitted in the department of neonatology of children's hospital affiliated to chongqing medical university from january 2015 to december 2019;② 12-lead ecg and/or 24-hour dynamic ecg suggest arrhythmias, including children with sinus tachycardia and sinus arrhythmia. exclusion criteria:not have
epidural stimulation to restore voluntary movement following spinal cord injury

Conditions: Spinal Cord Injuries

Summary: this proof-of-concept case series will prospectively use magnetic resonance imaging (mri) evidence of spared spinal cord neural fibers to guide the selection of 2 research participants to receive a surgically implanted epidural stimulator with the goal of restoring voluntary movement after spinal cord injury (sci). because mri evidence of spared spinal cord neural fibers demonstrated significant relationships with responsiveness to epidural stimulation in sci in retrospective studies, the proposed study is a traditional feasibility study - a prospective investigation to be used to capture preliminary safety and effectiveness information to determine if mri can/should be used in planning a future pivotal study.

this is an investigator-initiated proof of concept study performed at the university of colorado anschutz medical campus (cu anschutz). this 2-case proof-of-concept study will include 2 research participants with motor-complete sci to evaluate the performance of the medtronic epidural stimulator for restoring voluntary movement below the level of injury. participants will be enrolled at cu anschutz. screening data will be reviewed to determine participant eligibility. two participants who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. the following treatment regimen will be used: epidural stimulation + 6 months of intensive outpatient physical therapy. total duration of study participation will be 8 months.

Eligibility criteria:
inclusion criteria: 1. american spinal injury association impairment scale b spinal cord injury diagnosis 2. beyond 6 months of injury date 3. spinal cord injury at a level range of cervical 7 to thoracic 8 (c7-t8) with signs of upper motor neuron injury 4. 18 years or older 5. height 5'1" to 6'3" 6. weight 250 lbs or less 7. sufficient upper extremity strength to manage a stability aide 8. magnetic resonance imaging evidence of spared spinal cord neural fibers exclusion criteria: 1. claustrophobia and/or other contraindications to magnetic resonance imaging 2. unstable or symptomatic cardiorespiratory issues, in the opinion of the investigators 3. recent (within 3 months) history of fracture, contractures, pressure sore, deep vein thrombosis, urinary tract infection, or other infections that might interfere with interventions 4. contraindications to epidural stimulator implantation surgery 5. received botox injections into the lower extremities within the past 6 months 6. pregnancy 7. cauda equina injury 8. any other neurological disorder besides spinal cord injury
e-tegra stent graft system in the treatment of infra-renal abdominal aortic aneurysms

Conditions: Abdominal Aortic Aneurysm; AAA

Summary: the purpose of this study is to evaluate clinical and technical success as well as safety and feasibility of the e-tegra stent graft system used in endovascular treatment of infrarenal aortic aneurysm.


Eligibility criteria:
inclusion criteria: * patients must comply with the indications for use * patient must have an infrarenal aortic aneurysm with diameter \>5cm or an infrarenal aortic aneurysm with 4 to 5cm that has increased in size by 0.5cm in the last 6 months * patient must be available for the appropriate follow-up times for the duration of the study * patient has signed the informed consent before intervention exclusion criteria: * patients with one of the contraindications as indicated in the instructions for use * patients with infectious aneurysm * patients with inflammatory aneurysm * patients with pseudoaneurysm * patients with ruptured or traumatic aneurysm * patients with suprarenal, juxtarenal, or pararenal aneurysm * patients with aortic dissection * patients with a reversed conical neck that is defined as a \>3mm distal increase over a 15mm length * patients who have a congenital degenerative collagen disease or connective tissue disorder * patients with thrombocytopenia * patients with creatinine \>2.4 mg/dl immediately before the intervention * patients with hyperthyreosis * patients with malignancy needing chemotherapy or radiation * patients who are enrolled in another clinical study * patients with life expectancy of less than 24 months
natural history and results of dual chamber (ddd) pacemaker therapy of children with obstructive hypertrophic cardiomyop...

Conditions: Hypertrophic Cardiomyopathy

Summary: several studies have shown that specialized pacemaking devices (ddd pacing) can improve the symptoms associated with hypertrophic cardiomyopathy (hcm) in adults. in addition, studies have also shown that specialized pacemaking devices (ddd pacing) can improve conditions of hcm in children. however, growth of the body and organs, including the heart, is very rapid during childhood. therefore the long-term effects of ddd pacing in children are unknown. the purpose of this study is to examine the growth rate and nutrition of children with hcm. due to this heart condition and the restrictions that are often placed on the child's activity level, children with hcm may grow at a slower rat and may have a greater tendency to be overweight. children participating in the study will have their growth rate and nutritional status measured before the study begins and throughout the course of the study. findings in this research study will not directly benefit the patients participating in it. however, information gathered as a result of this study may lead to improvements in the management of children with hcm in the future.

several studies have shown that dual chamber (ddd) pacemaker therapy relieves lv outflow obstruction and improves symptoms in most adult patients with obstructive hypertrophic cardiomyopathy (hcm). it is however, uncertain whether ddd pacing will be efficacious in children with obstructive hcm, because of evolving cardiac morphology and increased lv hypertrophy and outflow obstruction associated with rapid body growth. we propose to monitor clinical progress, and cardiac morphologic and hemodynamic changes over several years following implantation of a ddd pacemaker in children who present with obstructive hcm between the ages of 5 to 15 years. functional status, myocardial ischemia, arrhythmias, and lv outflow obstruction will be evaluated by exercise tests, echocardiography, thallium scintigraphy, holter monitoring, electrophysiologic and cardiac catheterization studies. the results of pacemaker therapy will be compared with the findings in a cohort of young patients with obstructive hcm who elect not to be treated with ddd pacemaker.

Eligibility criteria:
* inclusion criteria: ddd pacemaker therapy children of either gender, aged 5 to 15 years. presence of lv hypertrophy and lv outflow obstruction. exclusion criteria: ddd pacemaker therapy other systemic disease that prevent evaluation by echocardiography or cardiac catheterization. chronic atrial fibrillation. positive pregnancy test. inclusion criteria: cohort study children of either gender, 5 to 20 years (children greater than 15 years will be included if there is access to reliable previous catheterization data). presence of lv hypertrophy and lv obstruction. exclusion criteria: cohort study other systemic disease that prevent evaluation by echocardiography or cardiac catheterization. chronic atrial fibrillation. positive pregnancy test.

Keywords: pacemaker pediatric obstructive hcm
poor response to monoclonal therapy in asthma

Conditions: Asthma

Summary: asthma affects 8% of the entire population. 4-5% of asthma sufferers have severe asthma, characterised by recurrent exacerbations (worsening of symptoms leading to the person having a bout of corticosteroids and/or antibiotics), significant symptoms and lack of response to the most widely used therapy, corticosteroids. there is now new types of treatments (antibody drugs) which are licensed to manage severe asthma such as anti-il5. there is evidence anti-il5 and other similar antibody drugs are effective at reducing asthma exacerbations and reduce the need for oral corticosteroids for those that have severe asthma. however, some patients respond poorly to anti-il5 and the investigators would like to find out why this happens. it is hoped that the investigators can identify the mechanism of poor treatment response to anti-il5. it is also hoped that the investigators can understand why symptoms worsen to the point of requiring antibiotics and/or steroids (also known as an exacerbation) for those prescribed anti-il5.


Eligibility criteria:
inclusion criteria: case participants: * aged 18 - 80 years old * able to give informed consent * all patients identified as being suitable for anti-il5 therapy by the asthma mdt will be considered for study enrolment. this assessment by the mdt for participants to be eligible includes: * a measure of compliance with current asthma medication, * confirmation of asthma diagnosis * suitability for anti-il5 therapy based on blood eosinophil counts, * asthma exacerbation rates * prednisolone dose. * confirmation of treatment requires at least two asthma specialists to agree that this is the correct course of action * patients must first demonstrate over 75% compliance with inhaled and/or oral corticosteroid therapy the asthma mdt and difficult asthma clinic normally assess patients between 18-80 years so only patients in this age range will be approached. all patients will be able to give informed consent for study participation. exclusion criteria: case participants: • pregnancy inclusion criteria: control participants: * aged between 18-80 years old. * able to give informed consent exclusion criteria: control participants: * pregnancy * underlying respiratory conditions

Keywords: severe asthma anti-il5 asthma